Clinical Trial Project Manager, Clinical Delivery-EMP

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

The purpose of the Clinical Trial Project Manager (CTPM) role related to exploratory, and bio-pharmaceutics clinical development is to lead study teams of internal and external partners in the planning and execution of studies within the Phase 1 clinical development plan. The CTPM achieves this while ensuring quality, on time, and on-budget fulfillment of study results. The CTPM may also support non-study project assignments to innovate and improve the business.

The CTPM will seek knowledge from internal and external sources and use this information to shape development plans and ongoing improvement transformations.

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Collaborate with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

• Plans and implements study management activities including timeline, risk, and budget management, etc.
• Serves as the trial level owner of communication across functional personnel TPO (Third Party Organization), communication of timelines, unanticipated issues, and solutions and actions for which such personnel are held accountable.
• Proactively identifies and communicates appropriately the status of ongoing projects, issues, and risks that may affect the project schedule and delivery of the study.
• Provides oversight and/or approval of cross-functional vendor results.
• Partners with exploratory and bio-pharmaceutics clinical development colleagues to acquire study cost estimates. Tracks study-level spend and change needs.
• Anticipates, handles, and advances issues as appropriate.
• Holds business partners accountable to agree upon expectations and results.
• Interacts closely with the TPO to plan and implement the study at each site.
• Partners to identify, qualify, and select sites.
• Partners with cross-functional personnel to develop and negotiate detailed clinical study budgets.
• Partners with Contracts personnel to initiate contracts.
• Leads and supervises investigator payments, when needed.
• Ensures site initiation, monitoring and close out visits are performed by the site monitor. Reviews monitoring reports as applicable and ensures solutions/follow up of data queries and coordinating issues. Advances unresolved quality and/or performance issues, as vital.

• Provides cross-functional clinical process expertise and input for timeline development as the need arises.
• Leads study development in coalition with internal and external partners.
• Initiates contracts with investigators, consultants, and other external entities, as appropriate.
• Communicates study-level requirements to vendors and reviews third party tasks (including data acquisition, dataset requirements, database build) to ensure they meet protocol requirements and other Lilly requirements and enforce to oversight plan.
• Consults with internal and external partners to ensure feasibility of enrollment plan, study design, and understanding of local regulatory and ethics approval requirements for successful protocol implementation.
• Develops and/or approves trial level site activation documents (e.g., Monitoring Plan, Investigator Training).
• Plans, runs, and oversees study enrollment.
• Partners with Product Delivery to ensure accurate labeling, creation of drug accountability forms, reconciliation of unblinding summary, and other CT (Clinical Trial)…